Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastična sredstva - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 in 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastična sredstva - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberkuloza, odporna proti multidrugom - antimikobakterij - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 in 5. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

amicus therapeutics europe limited - migalastat hydrochloride - fabryjeva bolezen - migalastat - galafold je indiciran za dolgotrajno zdravljenje odraslih in mladostnikov, starih 16 let in več, s potrjeno diagnozo fabryjeve bolezni (pomanjkanje α-galaktozidaze a) in ki imajo amenabilno mutacijo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin, metformin hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - za bolnike z tipa 2 sladkorna bolezen:efficib je indicirano kot dodatek k dieti in telesni za izboljšanje glycaemic nadzor pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom sam ali tistih, ki se že zdravijo z kombinacijo sitagliptin in metformin. efficib je navedeno v kombinaciji z sulfonil sečnine (i. trojna kombinacija terapija), kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in sulfonil sečnine. efficib je označen kot trojna kombinacija terapije z ppar agonist (i. a thiazolidinedione) kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in ppar agonist. efficib je prikazano tudi kot dodajte na insulin (i. , trojna kombinacija terapija), kot dodatek k prehrani in vadbi za izboljšanje glycaemic nadzor pri bolnikih, pri stabilen odmerek insulina in metforminom sam ne zagotavljajo ustrezne glycaemic nadzor.

Evropska unija - slovenščina - EMA (European Medicines Agency)

intervet international bv - ibafloxacin - antibakterij za sistemsko uporabo - dogs; cats - psi:ibaflin je indicirano za zdravljenje naslednjih pogojev pri psih:v stiku s kožo okužb (pyoderma - površinske in globoke rane, abscesi), ki jih povzročajo občutljivi sevi stafilokoki, escherichia coli in proteus mirabilis;akutna, enostavno sečil-trakt okužb, ki jih povzročajo občutljivi sevi stafilokoki, vrste proteus, enterobacter spp. , e. coli in klebsiella spp. ;dihal-trakt okužb (zgornji del prebavil), ki jih povzročajo občutljivi sevi stafilokoki, e. coli in klebsiella spp. ibaflin gel je navedeno pri psih za zdravljenje naslednjih pogojev:v stiku s kožo okužb (pyoderma - površinske in globoke rane, abscesi), ki jih povzročajo občutljivi patogeni, kot so staphylococcus spp. , e. coli in p. mirabilis. mačke:ibaflin gel je navedeno v mačke za zdravljenje naslednjih pogojev:v stiku s kožo okužb (mehka tkiva okužb - rane, abscesi), ki jih povzročajo občutljivi patogeni, kot so staphylococcus spp. , e. coli, proteus spp. in pasteurella spp. ;zgornje dihalne-trakt okužb, ki jih povzročajo občutljivi patogeni, kot so staphylococcus spp. , e. coli, klebsiella spp. in pasteurella spp.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, metformin hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - za bolnike z diabetesom tipa 2, bolezni:janumet je indicirano kot dodatek k dieti in telesni za izboljšanje glycaemic nadzor pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom sam ali tistih, ki se že zdravijo z kombinacijo sitagliptin in metformin. janumet je indicirano v kombinaciji z sulfonil sečnine (i. , trojna kombinacija terapija), kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in sulfonil sečnine. janumet je indicirano kot trojna kombinacija terapije z ppar agonist (i. , thiazolidinedione) kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in ppar agonist. janumet je prikazano tudi kot dodajte na insulin (i. , trojna kombinacija terapija), kot dodatek k prehrani in vadbi za izboljšanje glycaemic nadzor pri bolnikih, pri stabilen odmerek insulina in metforminom sam ne zagotavljajo ustrezne glycaemic nadzor.

Evropska unija - slovenščina - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - zdravila, ki se uporabljajo pri diabetesu - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Evropska unija - slovenščina - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - imunosupresivi - revmatoidni artritis (ra)kineret je navedeno pri odraslih za zdravljenje znakov in simptomov ra v kombinaciji z metotreksatom, z nezadosten odziv na sam metotreksat. covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml. periodic fever syndromeskineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:cryopyrin-associated periodic syndromes (caps)kineret is indicated for the treatment of caps, including:neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca)muckle-wells syndrome (mws)familial cold autoinflammatory syndrome (fcas)familial mediterranean fever (fmf)kineret is indicated for the treatment of familial mediterranean fever (fmf). kineret je treba v kombinaciji z colchicine, če je primerno. Še vedno je diseasekineret je navedeno pri odraslih, mladostnikov, otrok in dojenčkov, starih od 8 mesecev in več s telesno maso 10 kg ali več, za zdravljenje še vedno je bolezen, vključno s sistemsko mladoletnike idiopatsko artritis (sjia) in odrasle-nastop še vedno je bolezen (aosd), z aktivnim sistemske značilnosti zmerno do visoko aktivnosti bolezni, ali pri bolnikih s nadaljevanje aktivnosti bolezni po zdravljenju z nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil) ali glucocorticoids. kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (dmards).

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi winthrop industrie - liksisenatid - diabetes mellitus, tip 2 - drugs used in diabetes, glucagon-like peptide-1 (glp-1) analogues - lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.